Regulatory Affairs Director

2 weeks ago


Waltham, Massachusetts, United States Dyne Therapeutics Inc Full time
Job Title: Regulatory Affairs Director

Dyne Therapeutics Inc is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing our regulatory strategy to ensure compliance with regulatory requirements.

Key Responsibilities:

  • Develop and implement regulatory strategies to support clinical development and registration of pharmaceuticals
  • Provide global regulatory guidance to program teams on requirements for clinical development and registration
  • Oversee preparation, review, and submission of regulatory documents to ensure compliance with regulatory requirements
  • Manage timelines and preparation of meeting requests and briefing documents
  • Author/edit documents to support regulatory submissions
  • Compile, review, and submit clinical trial and marketing registration applications, amendments, and supplements
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports
  • Support the organization with health authority meetings
  • Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease
  • Manage staff and vendors as needed to support regulatory activities

Requirements:

  • Minimum of a bachelor's degree in life science or related discipline
  • Minimum of 8-10 years of experience in regulatory strategy in a clinical-stage biotechnology company
  • Strong experience with CTD format and content regulatory filings
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
  • Experience in Health Authority Meetings
  • Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus
  • Ability to work independently to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones
  • Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management
  • Outstanding communication skills (verbal and written), regulatory writing skills, and willingness to share knowledge and lessons learned


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